BEUDAMED
    FDA Enforcement Class III Ongoing

    IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

    Recall: Z-0901-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0901-2022
    Event ID
    89677
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Volcano Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 20, 2022
    Initiation Date
    January 24, 2022
    Classification Date
    April 8, 2022
    Address
    3721 Valley Centre Dr Ste 500, N/A, San Diego, CA, 92130-3328, United States

    Description

    IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

    Reason

    Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.

    Code Info

    All MM-TSM units, Device Identifier (DI): 00845225012915

    Distribution

    US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN OUS: JP, DE, GB, NL, IT

    Quantity

    47